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Completed

NCT Number: NCT03252002

Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single and Multiple Oral BAY1101042 Tablet Doses in Healthy Male Subjects

To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in healthy male subjects after a single oral dose and multiple once daily dosing for 7 days

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Key information

Conditions

Healthy Volunteer Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical-Research-Services Mönchengladbach GmbH, Mönchengladbach, North Rhine-Westphalia, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The informed consent must be signed before any study specific tests or procedures are done.
  • Healthy male subject.
  • Age: 18 to 45 years (inclusive) at the screening.
  • Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m2.
  • Ability to understand and follow study-related instructions.

Exclusion criteria

  • Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
  • Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening.
  • Regular use of medicines.
  • Smoking more than 10 cigarettes daily.
  • Systolic blood pressure below 100 or above 145 mmHg (at screening).
  • Diastolic blood pressure below 50 or above 90 mmHg (at screening).
  • Heart rate below 50 or above 90 beats/ min (at screening).

Treatment and study plan

BAY1101042

Drug

Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days

Placebo

Drug

Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame: Approximately 19 days

    Assessment of treatment emergent adverse events from first study drug intake until follow up

Secondary outcomes

  1. AUC(0-24) of BAY1101042

    Time frame: At day 1

    AUC(0-24): area under the concentration vs. time curve from zero to 24 hours after single dose

  2. AUC(0-24)/D of BAY1101042

    Time frame: At day 1

    AUC(0-24)/D: dose-normalized area under the concentration vs. time curve from zero to 24 hours after single dose

  3. Cmax of BAY1101042

    Time frame: At day 1

    Cmax: maximum observed drug concentration after single dose

  4. Cmax/D of BAY1101042

    Time frame: At day 1

    Cmax/D: dose-normalized maximum observed drug concentration after single dose

  5. AUCτ,md of BAY1101042

    Time frame: At day 9

    AUCτ,md: area under the concentration vs. time curve for the actual dosing interval after multiple dose

  6. AUCτ,md/D of BAY1101042

    Time frame: At day 9

    AUCτ,md/D: dose-normalized area under the concentration vs. time curve for the actual dosing interval after multiple dose

  7. Cmax,md of BAY1101042

    Time frame: At day 9

    Cmax,md: maximum observed drug concentration after multiple dose

  8. Cmax,md/D of BAY1101042

    Time frame: At day 9

    Cmax,md/D: dose-normalized maximum observed drug concentration after multiple dose

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Single/Multiple Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY1101042 Given as 5 mg MR Tablet After Single Oral Dosing Followed by Once Daily Dosing for 7 Days in 12 Healthy Male Subjects Per Dose Step in a Randomized, Placebo Controlled, Single Blind, Group Comparison Design

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 16, 2017
Registry last updated
Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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